Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.DescriptionPURPOSE
The Assoc. BioServices Project Manager is the primary point of contact for our external customers. The focus of the Assoc. BioServices Project Manager is to provide exceptional customer service while ensuring that all work meets Q2 Solutionsscientific standards working under the direction of senior members of the BioServices Project Management team. RESPONSIBILITIES
Job Requirements REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis.
- Serve as Principal Investigator for GLP studies.
- Work closely with Technical Writing and QA to ensure projects are completed on schedule.
- Review validation and bioanalytical reports for completeness.
- Maintain all communication with customers providing daily updates on all active projects.
- Work with the customer to resolve sample discrepancies.
- Monitor the progress of all assigned projects and alert management if work falls behind schedule.
- Provide regular project status updates to management.
- Submit accurate weekly assessment of resource requirements for scheduling purposes.
- Prepare validation and sample analysis plans.
- Review data (run binders, data tables, etc) for regulatory compliance and scientific quality.
- Address issues from QC and QA review for run binders.
- Conduct thorough investigations of all failed runs.
- Organize method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report..
- Coordinate customer visits.
- Visit customers.
- Work with business development staff to prepare quotes for assigned customers.
- Approve validation experimental designs.
- Prepare data for external presentations.
- Ensure projects are archived in accordance with Q2 SolutionsSOP.
- Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Ability to achieve results through collaborative efforts with others.
- Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.
- Experienced in sample extraction and routine laboratory procedures.
- Understanding of method development and validation of assays
- Ability to interact with external and internal clients, and work to objectives/timelines
- Excellent attention to detail and communication skills
- Ability to follow verbally communicated procedures
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
EEO Minorities/Females/Protected Veterans/Disabled
- Bachelor's Degree in a scientific field with 3 years' related experience; or equivalent combination of education, training and experience in GLP laboratory environment.